Identity
- Trade Name
- OKO EUDAMED
- Device Name
- Tablica okulistyczna EUDAMED
- Model / Reference
- OKO EUDAMED- EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05903684803484 EUDAMED
- Basic UDI-DI
- 590368480M007BM EUDAMED
- EMDN Code
- Z1212012001 VISUAL FUNCTIONAL ASSESSMENT EQUIPMENT EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Poland EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Oko by Meden Inmed Sp Z O O — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 590368480M007BM | Class I | Active |
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Manufacturer
- Manufacturer
- Meden-Inmed Sp. Z O.o.
- EUDAMED SRN
- PL-MF-000001670
Sources (1)
- EUDAMED 3c1b8f3c-858e-4aa4-a21a-a2f6ca95dffd 61 fields · synced Jun 17, 2026